Showing posts by Christine QuaganShow all
Emerging biotech companies must master many challenges in bringing a product to market. Even the acronyms common to early development, like IND (Investigational New Drug Application), SAD (single ascending dose), and MAD (multiple ascending dose) imply that a company must know how their treatment impacts the body, how to analyze study results, and how to express their findings to regulatory authorities. The expertise of medical writers is valuable in helping an emerging biotech reach its drug development goals.
Recently, the Medical Writing Team at PROMETRIKA completed our second New Drug Application (NDA) submission within a year.
Recent articles in Medical Writing, the Journal of the European Medical Writers Association, recommend collaboration between medical writers and biostatisticians.